Iso 8 Clean Room Guidelines

Iso 8 is the least clean cleanroom classification.

Iso 8 clean room guidelines.

Federal standard 209e equivalent. Class 100 000 associated eu gmp grade. Iso clean room classifications are rated according to how much of a particulate of a specific size exists per cubic meter within a given enclosure see second chart. Usually manufacturers will define an airborne particulate concentration standard class such as iso 14644 1 iso 8 at rest outline gowning and a pressure cascade regime defining a clean corridor design or a dirty corridor design.

See our cleanroom classifications page. Clean room classifications are based on an eight class rating system with an iso class 1 cleanroom being rated the most particle free and iso class 8 allowing the most particles. Information on iso 14644 1 2015 class 8 cleanroom classification. Iso 14644 7 2004 part 7.

Considerations for iso class 8 cleanrooms. A cleanroom must have less than 35 200 000 particles 0 5 micron per cubic meter and 20 hepa filtered air changes per hour. In theory for an entire room to reach iso 6 air cleanliness you need to enter the cleanroom via an iso 8 ante room then go through an iso 7 to finally get into the iso 6 as shown in the image. In reality however you can reach an iso 6 clean room with 1 recommendation is 2 airlock.

D recommended air changes per hour ach. 5 48 typically measured micron sizes. Maximum allowable concentrations by cleanroom class.